Medical Component and Device Manufacturing
Helix Medical is a global custom manufacturer for the medical device and healthcare industries with seven manufacturing operations worldwide. Medical manufacturing capabilities include component and device design and development, silicone molding, thermoplastic molding, silicone extrusion, thermoplastic extrusion, catheter development and manufacturing, assembly, packaging, and engineering services. Helix Medical operates FDA-registered medical device facilities, certified ISO 13485 with Class 7 & 8 cleanrooms.
Established in 1984, Helix Medical currently manufactures in California, Indiana, Massachusetts, Costa Rica, Germany, Ireland, and China.
Medical Device Design and Development
With the acquisition of MedVenture, Helix Medical now has the ability to offer you more capabilities in design, development, and engineering. Our MedVenture Development Group provides comprehensive medical device and component design and development services from industrial design and prototyping to design for manufacturability support for a single component program or complete solutions for minimally invasive surgical and catheter-based devices.
We co-develop breakthrough medical device designs using the latest design tools and techniques to create a product that is robust, safe, effective, and within budget. We develop manufacturing processes that ensure effective product launch and we can validate processes across the entire spectrum of product development, from bottom-up creation to parallel line-transfer.
Molding capabilities include low- to high-volume injection molding, liquid injection molding (LIM), transfer/compression molding, micro-molding, insert molding, over-molding, and two-shot molding. Additional specialties include patented cold runner technology for silicone molding, advanced hot runner systems for both valve gate and open tip thermoplastics to reduce overall scrap, scientific injection molding, plus expertise in short- and long-term implantable LSR and HCR silicones.
Helix Medical offers a wide range of value-added services from sterilization, assembly, and packaging to annealing, thermoforming, and pad printing.
Extrusion capabilities encompass a wide variety of tubing types, including single- and multi-lumen tubing, braided reinforced tubing, cord, color stripe, close tolerance, profiles and tapes, as well as co-extrusion, pigmenting, and radiopacity.
Our close tolerance extrusions, in both silicone and TPE’s, provide the precision and quality required for the most demanding applications. Value added services include cut-to-length, skiving, pad printing, bonding/gluing, punching, parylene coating, proprietary striping, and a wide selection of long-term implant grade, medical grade, and pharmaceutical grade silicones.
The Helix Medical joint venture company VistaMed provides innovative catheter solutions—from concept design to product development and high-volume manufacturing—covering a full range of technologies. Custom catheter capabilities include extrusion, insert molding, braiding, tip forming, bonding, precision hole drilling, laser cutting, balloon forming, printing, packaging, labeling, and sterilization.
Cambus Medical, also a Helix Medical joint venture partner, designs, develops, and manufactures critical components for minimally invasive medical devices used in diagnostic and therapeutic interventions. The company’s principal focus is the development and manufacture of stainless steel hypotubes and catheter shafts used in angioplasty balloon catheters and stent delivery systems where the highest levels of performance are required. An ISO 13485 registered medical technology company; explore Cambus Medical's capabilities.
Helix Medical also manufactures the HelixMark® brand of platinum-cured silicone tubing and fluid handling components for pharmaceutical, biotech and IVD. HelixMark products are available off-the-shelf in an extensive array of product types and sizes. Tubing products include PharmaFocus, peristaltic pump tubing, braided reinforced, standard, color stripe, close tolerance tubing, stoppers and gaskets, custom assemblies, and custom packaging. We offer a wide choice of silicones and material certification and lot traceability is included with every product.
View the HelixMark® Silicone Products Catalog.
Quality You Can Count On
We work closely with the companies we serve to implement customized validation and quality assurance systems. Our objectives are to ensure compliance with all FDA, ISO, and MDD requirements, and to fulfill each of our customer's specific requirements.
- FDA-registered facilities in California and Ireland
- ISO 13485 certification
- ISO 14644 Class 7 & 8 cleanrooms
- CDPH-licensed medical device manufacturer
- cGMP and QSR compliant globally
- Climate-controlled metrology laboratory
- First article inspections, process capability studies, Gauge R&R
A Lean Manufacturing Partner
We draw on extensive material, process, and tooling expertise combined with integrated project management to deliver validated processes. Using lean manufacturing tools such as Kaizen, Value Stream Mapping, 3Ps, Six Sigma, and scientific injection molding capability, we drive out waste, optimize value adding activity, and shrink lead times.